Project Description
GMP System Validation in SAP
Good Manufacturing Practice for pharmaceuticals and active ingredients efficiently implemented in SAP!
The SERKEM Solution in Detail
GMP System Validation in SAP
The GMP or Good Manufacturing Practice describes a form of warranty that pharmaceuticals and active ingredients correspond to the highest grade at quality requirements and follows a pointed quality management. There are differences between GMP and cGMP. GMP are the quality requirements in Germany, cGMP is the equivalent in the USA.
To keep the GMP guidelines, the SAP system need to have a comprehensive quality assurance system. In addition it has to be completely documented and controlled.
First of all it has to be differentiated between qualification and validation:
The 4 validation phases
The design qualification is the documented verification that the design of the processes or of the system fulfills the requirements of the specification sheet, the GMP and the general quality assurance.
The following documents can be checked (an extract):
- R & I schemes (rule and instrumentation schemes)
- Process and facility description
- Layouts
- Specification sheets
- Process flow diagrams
The installation qualification is the corresponding verification that the process, the system or the infrastructure are built and installed like the defined specifications, specification sheets and installation requirements.
The installation qualification should include the following (an extract):
- Supplier audits
- Data sheets
- Inspection certificates
- Material verifications
- Operation and maintenance manuals
The operations qualification is the documented verification that the process or system works permanently, how specified, and can fulfill all the function requirements.
The following points have to be checked (an extract):
- Interfaces
- Normal functions
- Manual functions
The performance qualification is the documented verification that the critical processes or critical systems, which were defined in the risk analysis, correspond reliably and permanently to a regulated process workflow.
V-model for quality assurance
For the validation of computer-based systems, a so-called V model is often used as reference model. The advantage is that this kind of model can be shown and used in many different forms. Though, this can lead to partially unclear and ambiguous presentations.
The v-model has its name through the characteristically presentation of the letter „v“. The left axis forms the different specification phases and the right axis the relative testing phases.
Therefore, the v-model is very suitable for the presentation of specification phases and the belonging testing phases as wells as for the appropriate adjustment to previously prepared specifications, user requirements and system specifications.
Phases of the v-model
At the user requirements, the process-oriented as well as operation-based requirements of the user or the process owner are registered:
Example
Process-based: Only certain users should receive the access to the system.
Operation-based: The system need to have a password protection according to a certain template.
At this document, the user requirements are further detailed and the appropriate operations specified.
Example
The user has to enter the user name and password in a modal dialogue field.
Also named design specifications, the technical requirements map the explanations for the developer how the system specifications have to be implemented. It´s specified, for example, which specific parts have to be deposited in the coding of a database table.
Are these phases completed and the first validation implemented, so the realization follows. Depending on the procedure, the appropriate tests will be executed. So the v-model in particular relation to GMP applies in both implementation steps DQ and IQ.
If you need assistance at the validation of your SAP system, feel free to contact us.
